Reata Pharma (RETA) Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
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Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
March 1, 2021 6:30 AM ESTPLANO, Texas, March 01, 2021 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (Reata, the Company, or we), a clinical-stage biopharmaceutical company, today announced that it has submitted a New Drug Application (NDA) for bardoxolone methyl (bardoxolone) for the treatment of chronic kidney disease (CKD) caused by Alport syndrome to the U.S. Food and Drug Administration (FDA).
This NDA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. The submission includes a request for Priority Review, which, if granted, would shorten the FDAs review of the NDA to eight months from the time of... More
